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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, vitreous aspiration and cutting, ac-powered
510(k) Number K102222
Device Name ULTIMATE VIT ENHAMCER (UVE)
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
557 MC CORMICK STREET
SAN LEANDRO,  CA  94577
Applicant Contact LINDA UPTON
Correspondent
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
557 MC CORMICK STREET
SAN LEANDRO,  CA  94577
Correspondent Contact LINDA UPTON
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/06/2010
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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